Promoting Tolerance of Children’s Feelings | Not Recruiting
Promoting Tolerance of Children’s Feelings

Trial Source

Health Conditions
  • Anxiety
Not Recruiting
Recruitment Status
ISRCTN77196667
Primary Trial ID Number
Summary
In a randomised controlled trial of childhood anxiety in the presence of a current parental anxiety disorder, the principal research questions are the following: Phase 1 1. In comparison to parents who receive a control intervention, parents who receive an intensive tolerance of children’s negative emotion (TCNE) intervention will: 1.1. Report lower anxiety when taking part in a stressful task with their child 1.2. Exhibit lower levels of expressed anxiety and negativity 1.3. Display lower levels of physiological arousal, when engaged in mildly stressful task with their child. 2. In comparison to children in the control condition, children of parents who receive the tolerance of children’s negative emotion (TCNE) intervention will: 2.1. Report lower levels of anxiety 2.2. Exhibit lower levels of expressed anxiety 2.3. Have reduced physiological (heart rate) arousal whilst completing a stressful task with their parent. Phase 2 1. In comparison to children in the control condition, children of parents who receive the tolerance of children’s negative emotion (TCNE) intervention as an adjunct to standard clinic treatment will demonstrate improved treatment outcomes in terms of overall improvement, recovery from anxiety diagnosis, and reduction in anxiety symptoms. 2. Children’s treatment outcomes will be mediated by change in parental tolerance of children’s negative emotions.
Primary Outcome Measures
  • Primary indicator of recovery measured post treatment
Secondary Outcome Measures
  • Change in parental interactive behaviours measured at the end of study
Research Question
  • In a randomised controlled trial of childhood anxiety in the presence of a current parental anxiety disorder, the principal research questions are the following: Phase 1 1. In comparison to parents who receive a control intervention, parents who receive an intensive tolerance of children’s negative emotion (TCNE) intervention will: 1.1. Report lower anxiety when taking part in a stressful task with their child 1.2. Exhibit lower levels of expressed anxiety and negativity 1.3. Display lower levels of physiological arousal, when engaged in mildly stressful task with their child. 2. In comparison to children in the control condition, children of parents who receive the tolerance of children’s negative emotion (TCNE) intervention will: 2.1. Report lower levels of anxiety 2.2. Exhibit lower levels of expressed anxiety 2.3. Have reduced physiological (heart rate) arousal whilst completing a stressful task with their parent. Phase 2 1. In comparison to children in the control condition, children of parents who receive the tolerance of children’s negative emotion (TCNE) intervention as an adjunct to standard clinic treatment will demonstrate improved treatment outcomes in terms of overall improvement, recovery from anxiety diagnosis, and reduction in anxiety symptoms. 2. Children’s treatment outcomes will be mediated by change in parental tolerance of children’s negative emotions.
Design Type
Sorry, this information is not available
Ethics Approval
ref: 12/SC/0022
Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Child
Participant Type
Patient
Trial Sample Size
65
Participant Inclusion Criteria
  • The trial is open to children with a current primary diagnosis of a major anxiety disorder whose parent (i.e. primary carer) also currently experiences high anxiety.
  • Child:
  • 1. Aged 7 to 12 years;
  • 2. Primary diagnosis of DSM-IV generalised anxiety disorder, social phobia, separation anxiety disorder, panic disorder/agoraphobia, or specific phobia (must be at least one current comorbid anxiety disorder).
  • Parent:
  • 1. Primary carer
  • 2. Cohabitates with child
  • 3. Currently experiences high anxiety on basis of
  • 3.1. Scoring above clinical cut-offs on the DASS-A
  • 3.2. Meeting diagnostic criteria for a current major anxiety disorder
  • 4. Male and female participants
Participant Exclusion Criteria
  • Child:
  • 1. Significant physical or intellectual impairment (including autistic spectrum disorders) that would impede treatment delivery
  • 2. Current prescription of psychotropic medication (or, if psychotropic medication is prescribed, it should have been at a stable dose for at least 8 weeks with agreement to maintain that dose throughout the study)
  • Parent:
  • 1. Significant intellectual impairment
  • 2. Severe comorbid disorder that requires intervention outside of BCAC (e.g. severe major depressive disorder, psychosis, substance/alcohol dependence).
Interventions
Guided cognitive behavioral therapy (CBT) self-help delivered via parents (four sessions, 3 face to face, 1 telephone) with adjunctive Tolerance for Children’s Negative Emotions therapy (four sessions, 3 face to face, one telephone) OR Eight sessions of Guided Cognitive Behaviour Therapy (CBT) self-help (6 face to face, 2 telephone) followed up after 4 months
Design Details
Sorry, this information is not available
Study Design
Randomised interventional treatment
Results Reporting
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Acronym
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Scientific Title
Promoting Tolerance of Children’s Feelings
Secondary Trial Identifying Number
11832
Website
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Study Funded By
Medical Research Council [MRC] (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
University of Reading (UK)
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment

01 Mar 2012

Recruitment End Date

31 May 2013

Trial End Date

31 May 2013

Date added to Registry

22 Mar 2012

Last Updated

22 Mar 2012